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Health Highlights: Jan. 18, 2019
Posted 3 days ago in Medical
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Gluten-Free Chicken Nuggets Recalled by Perdue Foods Possible wood contamination has led to the recall of more than 68,000 pounds of gluten-free chicken nuggets from Perdue Foods, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) says. The agency said there are no confirmed cases of... Read more
Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For Evenity (romosozumab)
Posted today in New Drug Applications
THOUSAND OAKS, Calif. and BRUSSELS, Jan. 16, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) for the approval of Evenity™* (romosozumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture after reviewing... Read more
FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin
Posted today in New Drug Approvals
INCHEON, KOREA – January 21, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin®i (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction... Read more
Is Air Pollution a Downer?
Posted today in Medical
MONDAY, Jan. 21, 2019 -- Air pollution may not only make it hard to breathe, but it may also make you unhappy, a new study suggests. In China, air pollution reportedly causes an average of 1 million premature deaths each year and costs its economy $38 billion. But it also affects people's happiness, according to researchers led by Siqi Zheng. She is an associate professor in the department of urban studies and... Read more
A Prescription for Feeling Young Forever
Posted today in Medical
MONDAY, Jan. 21, 2019 -- You know about the value of exercise for heart health and for staying strong and independent as you age. There's also proof that exercise keeps your body young physically as well as mentally. A British study involving cycling enthusiasts between the ages of 55 and 79 found that their physical shape and abilities rivaled those of people much younger. Being physically active affects muscle... Read more
Many Parents Wrong About What Prevents Colds in Kids
Posted today in Medical
MONDAY, Jan. 21, 2019 -- No parent wants to see their child catch a cold, but some take prevention measures that have little basis in science, a new survey shows. For example, 51 percent of parents said they give their child an over-the-counter vitamin or supplement to prevent colds, even though there's no evidence they work. Seventy-one percent of parents said they used "folklore" advice, such as not letting... Read more
Diet or Exercise -- or Both?
Posted today in Medical
MONDAY, Jan. 21, 2019 -- There's no doubt that an unhealthy diet and couch potato lifestyle put your health at risk, but when considering improvements, should you change one at a time or both at once? Northwestern University researchers found that it's not only doable, but also more effective, to change unhealthy behaviors simultaneously. Different groups of study participants were given a pair of changes to make.... Read more
Mandibular Contour Surgery Training System Beneficial
Posted 3 days ago in News for Health Professionals
FRIDAY, Jan. 18, 2019 -- An intraoral mandibular contour surgery (MCS) training system is effective for improving clinical surgery time and accuracy, according to a study published online Jan. 17 in JAMA Facial Plastic Surgery. Jia Qiao, M.D., from the Chinese Academy of Medical Sciences in Beijing, and colleagues enrolled 90 consecutive MCS patients and 15 craniofacial surgery fellow physicians (five per group) in... Read more
Assessing Symptoms After 4 Weeks of Psychotherapy Helpful in Teens
Posted 3 days ago in News for Health Professionals
FRIDAY, Jan. 18, 2019 -- Therapists implementing interpersonal psychotherapy for depressed adolescents (IPT-A) should routinely monitor depression symptoms and consider augmenting treatment for insufficient responders as early as week 4 of treatment, according to a study published in the January issue of the Journal of the American Academy of Child & Adolescent Psychiatry. Meredith Gunlicks-Stoessel, Ph.D., from... Read more
Wait Times Have Improved in VA Health Care System
Posted 3 days ago in News for Health Professionals
FRIDAY, Jan. 18, 2019 -- From 2014 to 2017, there were improvements in wait times in the Department of Veterans Affairs (VA) health care system, resulting in reduced wait times versus the private sector (PS) in 2017, according to a study published online Jan. 18 in JAMA Network Open. Madeline Penn, from the Department of Veterans Affairs in Washington, D.C., and colleagues conducted a retrospective cross-sectional... Read more
Medication Treatment for Substance Abuse Up in Facilities
Posted 3 days ago in News for Health Professionals
FRIDAY, Jan. 18, 2019 -- From 2007 to 2016, there was an increase in the proportion of substance use treatment facilities offering medication treatment (MT), according to a study published in the January issue of Health Affairs. Using data from national surveys, Ramin Mojtabai, M.D., M.P.H., Ph.D., from the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues examined national trends and... Read more
Mindfulness, Stress Linked to Menopausal Symptoms
Posted 3 days ago in News for Health Professionals
FRIDAY, Jan. 18, 2019 -- Higher mindfulness and lower stress are independently associated with lower menopausal symptom scores among midlife women, according to a study published online Jan. 17 in Climacteric. Richa Sood, M.D., from the Mayo Clinic in Rochester, Minnesota, and colleagues conducted a cross-sectional study involving women aged 40 to 65 years who completed questionnaires, including the Menopause Rating... Read more
FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes
Posted 5 days ago in New Drug Applications
PARIS and THE WOODLANDS, TX – January 17, 2019 – The Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) today voted eight to eight on the question of whether the overall benefits of Zynquista™* (sotagliflozin) outweighed the risks to support approval. Sotagliflozin is an investigational oral dual SGLT1 and SGLT2 inhibitor under regulatory review as... Read more
New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States
Posted 6 days ago in New Drug Applications
TOKYO and STAMFORD, Conn. – January 15, 2019 – Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD, “Purdue Pharma”) today announced that a new drug application has been submitted to the U.S. Food and Drug Administration (FDA) for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for the treatment... Read more
Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma
Posted 8 days ago in New Drug Approvals
ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 14, 2019-- Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved Cabometyx (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. HCC is the most common form of liver cancer and the fastest-rising cause of cancer-related death in the U.S.1 “This new... Read more
US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy
Posted 8 days ago in New Drug Applications
January 14, 2019 - Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial evaluating... Read more
FDA Approves Expanded Use of Adacel (Tdap) Vaccine for Repeat Vaccination
Posted 8 days ago in New Drug Approvals
BRIDGEWATER, N.J., Jan. 14, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration has approved the expanded use of Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat vaccination to help protect against tetanus, diphtheria and pertussis. It is now the first and only Tdap vaccine in the U.S. approved for a repeat dose in people 10 through 64... Read more
KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)
Posted 2 weeks ago in New Drug Approvals
CORALVILLE, Iowa, Jan. 07, 2019 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for two additional strengths of Apadaz, an immediate release (IR) combination of KemPharm’s prodrug,... Read more
Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous Contepo to Treat Complicated Urinary Tract Infections by FDA
Posted 2 weeks ago in New Drug Applications
DUBLIN, Ireland, Jan. 04, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted a priority review for Contepo™ (fosfomycin for injection)... Read more
Sprycel (dasatinib) Tablets Now Approved in Combination with Chemotherapy in Certain Pediatric Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Posted 2 weeks ago in New Drug Approvals
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel ® (dasatinib) tablets to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.1 Sprycel is the... Read more
Proteus Digital Health Launches Digital Oncology Medicines to Improve Patient Outcomes
Posted 4 days ago in Clinical Trials
January 17, 2019 – REDWOOD CITY, Calif. and MINNEAPOLIS, Minn. – Proteus Digital Health®, Inc., Fairview Health Services, and University of Minnesota Health announced today that for the first time cancer patients are using digital oncology medicines to support treatment regimens and improve outcomes. This advancement helps patients complete oral chemotherapy cycles while oncologists gain new insights... Read more
Two Positive Phase III studies of Tafenoquine for the Radical Cure of Plasmodium vivax Malaria Published in The New England Journal of Medicine
Posted 5 days ago in Clinical Trials
London UK; Philadelphia US; Geneva Switzerland - January 16, 2019 -- GSK and Medicines for Malaria Venture (MMV) today announced the publication of positive results from two phase III studies of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in The New England Journal of Medicine. Headline results from the DETECTIVE and GATHER studies, part of a... Read more
vTv Therapeutics Announces Publication of Comprehensive Data in Science Translational Medicine Detailing the Discovery and Clinical Development of TTP399, including Results of Phase 2 AGATA Study
Posted 5 days ago in Clinical Trials
HIGH POINT, N.C.--(BUSINESS WIRE)--Jan. 16, 2019-- vTv Therapeutics Inc. (Nasdaq: VTVT) today announced the publication of a paper in Science Translational Medicine showcasing the discovery and development of TTP399, an investigational, oral, small molecule, liver-selective glucokinase (GK) activator, as a potential treatment for diabetes. The paper reviews the scientific rationale underpinning the development of... Read more
New England Journal of Medicine Publishes Positive Results of the Pivotal Trial of Cablivi (caplacizumab) for Rare Blood Clotting Disorder
Posted 7 days ago in Clinical Trials
PARIS, Jan. 9, 2019 /PRNewswire/ -- The New England Journal of Medicine (NEJM) today published positive results of the Phase 3 trial of Cablivi® (caplacizumab) in adults with acquired thrombotic thrombocytopenic purpura (aTTP). aTTP is a rare, life-threatening autoimmune blood disorder characterized by extensive clot formation in small blood vessels throughout the body, leading to severe thrombocytopenia (very... Read more
Sound Pharmaceuticals Advances Phase 2 Hearing Loss Clinical Trial in Cystic Fibrosis
Posted 7 days ago in Clinical Trials
Seattle, WA and Charleston, S.C. -- January 14, 2019 -- Sound Pharmaceuticals (SPI) is pleased to announce that first-patient-in has been achieved in the STOP Ototoxicity Phase 2 clinical trial. This novel interventional study with SPI-1005 is aimed to prevent and treat ototoxicity in Cystic Fibrosis (CF) patients undergoing intravenous (IV) tobramycin for the treatment of acute pulmonary... Read more
